CytoDyn announced today that it has filed a reques

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CytoDyn announced today that it has filed a request with the U.S. Food and Drug Administration (FDA) for a preliminary meeting to discuss new clinical data which the Company believes further supports its objective to obtain Breakthrough Therapy designation (BTD) for leronlimab in the treatment of metastatic triple-negative breast cancer (mTNBC). The FDA had previously granted Fast Track designation to leronlimab for the treatment of mTNBC. Last month, the Company reported that the FDA had recommended such a meeting to provide preliminary advice prior to resubmission of a Breakthrough Therapy designation request.

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“We are extremely encouraged by the test results from these patients and continue to keep the FDA current on therapeutic benefit demonstrated by leronlimab for multiple cancer indications.”

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This provides some clarity (for me). We are going to meet, get guidance and resubmit the BTD application. Simultaneously, we will be able to tell FDA:" look these are the new results, as you can see they are extraordinary … what more proof do you really need ?". And follow their answer.

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The Food Drug and Cosmetic Act (21 USC 356) states that a request for a breakthrough therapy designation may be made concurrently with, or at any time after, the submission of an application for [the IND]. To maximize the benefits of the program, FDA encourages sponsors to submit breakthrough therapy designation requests by the time of the end-of-phase-2 meeting, and also before initiation of the clinical trial(s) intended to serve as the primary basis for demonstration of efficacy. Given that the primary intent of breakthrough therapy designation is to provide timely advice and interactive communications to help the sponsor design and conduct a drug development program as efficiently as possible, including the potential use of alternative trial designs, the full benefits of breakthrough therapy designation can only be realized during the development program, well in advance of the submission of the original BLA or NDA, or a supplement.

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We will be approved very likely, the question is whether FDA will take 60 days this time.